Local Trial Manager - South Africa

Iqvia; Gauteng; On-site; ZAR 600 000 - 900 000; Full time

Job summary

A leading provider of clinical research services is seeking a Clinical Trial Manager to oversee local trial management. The role involves ensuring compliance with clinical protocols, managing trial activities, and collaborating with various stakeholders to meet recruitment targets and maintain data quality. Ideal candidates will have a BA/BS in health or science and relevant trial management experience.

Qualifications

• 2+ years of trial management experience; 3-5+ years preferred for advanced roles.
• Strong knowledge of ICH-GCP and local laws.
• IT proficiency and willingness to travel.

Responsibilities

• Manage operational oversight of clinical trials from start-up to closeout.
• Ensure compliance with protocols and regulatory requirements.
• Lead local activities in compliance with SOPs and regulations.

Skills

Communication

Project Management

Risk Management

Education

BA/BS in health or science

Job description

Services Overview : Local Trial Management services provide local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.

Services / deliverables include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities.

Further, services will ensure the local trial team is delivering quality data and trial documents / records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements.

Partners with the Clinical Trial Assistant (CTA) / Investigator Document Assistant (IDA), Site Manager (SM), and Central Trial Manager (CTM) / Global Trial Manager to ensure overall study delivery at the country level.

Deliverables: Services rendered will adhere to applicable SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. and comply with relevant training requirements.

Contribute to quality Site Selection through participation in site feasibility, ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification report and country feasibility report.

Collaborates with central study team and local stakeholders for final site selection.

Ensures local / country team meets recruitment targets with high-quality data, on time, and within budget by providing input to study documents and leading local activities in compliance with SOPs and regulations.

This may include developing local trial procedures and tools, recruitment planning, risk management, and budget forecasting.

Acts as the primary company contact for assigned trial at the country level, participating in Investigator Meetings as needed.

May conduct local investigator meetings and drive study compliance by maintaining and updating trial management systems and reports.

Initiates corrective and preventive actions (CAPA) when deviations occur and communicates issues to study management and Quality & Compliance teams.

Contributes to site recruitment strategies and contingency planning in partnership with other functions.

Delivers vendor management at the country level, including reviewing and approving site and vendor invoices.

Manages local study supply when necessary and ensures high standards for study monitoring and team training.

Prepares country-specific informed consent forms and manages safety reporting for AEs/SAEs/PQCs.

Ensures trial subject safety, maintains inspection readiness, and manages data and document accuracy for audits and inspections.

Works closely with SM to implement CAPA for audits/inspections and may conduct site visits if delegated.

Ensures accurate financial reporting and trial delivery within budget, including forecasting and negotiation of site contracts if applicable.

Organizes and secures IEC/HA approvals to ensure compliance with local regulations.

May contribute as a trainer or to process initiatives, and reports time accurately.

Requires experience in managing complex early-phase trials and knowledge of local trial management services and processes.

Advanced level involves autonomy, process leadership, and metrics/KPIs management.

Primary interfaces include Provider Functional Manager, company contacts, CTAs, SMs, CTMs/GTLs, and other study personnel, as well as external vendors and ethics committees.

Educational requirements include a BA/BS in health or science, with 2+ years of trial management experience; 3-5+ years preferred for advanced roles.

Must have strong knowledge of ICH-GCP, company SOPs, local laws, and protocols, with IT proficiency.

Willingness to travel and proficiency in local language and English are required.

Good communication skills are essential.

IQVIA is a leading provider of clinical research services and healthcare intelligence, dedicated to improving patient outcomes worldwide.